NCT03618745

Brief Summary

To catch the high risk comatosed child to improve service and direct the limited resources to those children in countries with limited resources .

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2018

Completed
18 days until next milestone

First Posted

Study publicly available on registry

August 7, 2018

Completed
25 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

August 7, 2018

Status Verified

August 1, 2018

Enrollment Period

1 year

First QC Date

July 20, 2018

Last Update Submit

August 6, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • The percentage of recovery from coma

    clinical evaluation of the recovery symptoms and signs

    1 month

Interventions

CT brainDEVICE

noninvasive medical examination or procedure that uses specialized X-ray equipment to produce cross-sectional images of the body.

Eligibility Criteria

Age2 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Children admitted in Assiut University Hospital with impaired consciousness .

You may qualify if:

  • disturbed conscious level
  • Children's family signed consent of approval to participate in the study

You may not qualify if:

  • Children aged \<2 months or \>18 years.
  • Coma of traumatic etiology.
  • Coma as part of an anticipated terminal illness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Hanan Zaka

    World Health Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Gamal Askar, prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

July 20, 2018

First Posted

August 7, 2018

Study Start

September 1, 2018

Primary Completion

September 1, 2019

Study Completion

December 1, 2019

Last Updated

August 7, 2018

Record last verified: 2018-08